Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis

Assistance Publique - Hôpitaux de Paris27 enrolled

Overview

The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).

The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS. Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatitis Acute Biliary

Interventions

ultrasonography with or not sphincterotomyPROCEDURE

Early endoscopic ultrasonography and endoscopic sphincterotomy in case of common bile duct stone

Usual procedurePROCEDURE

The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria : * age \> 18 * predicted severe acute biliary pancreatitis (including age \> 80, BMI \>30, pre-existing organ failure, Modified Glasgow score \> 3) * timespan between onset and randomization \< 48 hrs * informed consent signed by patient or liable person in case of emergency Exclusion criteria : * non biliary pancreatitis * non severe pancreatitis * age \< 18 * timespan between onset and randomization \> 48 hrs * absence of consent * ongoing pregnancy * no social security insurance

Locations (1)

Hopital Cochin

Paris, France

Outcomes

Primary Outcomes

The difference between the SOFA score measured at entry in the study (day 0) and at day 8

Time frame: Day 8

Secondary Outcomes

Differences in SOFA score as measured at entry in the study and at day 15

Time frame: Day 15

Procedure-related morbidity

Time frame: at Day 15 to 3 months

Overall morbidity

Time frame: at day 15

Overall mortality

Time frame: at day 15

Difference in Balthazar's scores (CT-scan) at entry and at days 8 and 15

Time frame: at day 8 and day 15

Data from ClinicalTrials.gov

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